Late-Stage Clinical Applications Writer

7 days ago


Nationwide, United Kingdom RBW Consulting Full time

We are looking for a highly skilled Late-Stage Clinical Applications Writer to join our team at RBW Consulting. In this role, you will be responsible for writing CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.

Key Responsibilities:
  • Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
  • Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.

To succeed in this role, you will need a strong background in technical writing, with at least 5 years of experience in CMC regulatory submissions. You should also have in-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.

The salary range for this position is $90,000 - $110,000 per year, depending on experience. As a fully remote role with occasional travel to the R&D Centre in Paris, France, you will have the flexibility to work from anywhere while contributing to the development of groundbreaking therapies.


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